Many of the medical products today are controlled by software. The process of documenting, testing, verifying, and updating the software is becoming more mature. The methods that are used to assure proper operation of the software, and therefore the proper operation of the medical product are time consuming. As the software becomes more and more complex, the required testing and documentation grows dramatically. The off-the-shelf software and operating systems (such as the operating system available from Microsoft under the trademark Windows) have grown in complexity and flexibility. It is possible to interface with data bases, LAN systems, WAN systems, Internet, application programs, and literally tens of thousands of third party software packages. This flexibility is a great advantage to medical products but the complexity of the software, and the inability of the manufacturer to know what other software products might be added at a later date, make complete testing of the software virtually impossible.
For this reason, most medical products do not use standard operating systems such as the Windows operating system. They incorporate their own operating systems or put huge restrictions on the operating system they do use to limit the complexity and changeability, and therefore the flexibility of the system. These restrictions are imposed to assure the proper operation of the medical product. One example of this problem is seen with a prior art endoscope reprocessing system controlled by a standard computer, typically a PC (personal computer). This allows the flexibility to use standard data base programs to track the endoscopes and their reprocessing history. Modem computer and communications technology provide the ability to network systems together and interface directly with hospital computer systems. The capability exists to incorporate off-the-shelf bar code readers for tracking products (to reduce human error) and use endoscope identification features so the endoscope type is automatically transmitted to both the reprocessing machine and to one or more computers which store data about the endoscopes and their reprocessing. One problem with using a standard computer is the inability to completely test the software code to assure that no software bugs or errors exist in that code. Even if one were to spend the time it would take to test the code in every conceivable condition, the testing would need to be repeated as soon as new software (even an upgrade) was installed on the system.
With the proliferation of software viruses, this problem becomes even more critical. It would be possible to have perfect code when the system was installed only to have a virus get into the code and change it to a condition that would cause improper operation of the medical product.
One possible solution to this problem is to have a second computer monitoring the first computer to assure that everything it is doing is correct. This complicates the situation as it is then necessary to program and test a second system, and take steps to prevent the second system from also being exposed to a virus.
The present invention solves this problem by having a separate monitor system between the main operating computer and the actual hardware of the medical product, in this case the endoscope reprocessor. This monitor system can be as simple as a PLC (programmable logic controller) with some intelligence or as complicated as a second microprocessor operating on imbedded software (i.e. non-Windows operating system software or equivalent). The main function of the monitor system software is to monitor the critical steps or parameters of the medical reprocessor product (or other medical product, it being understood that the present invention is not limited to reprocessing endoscopes, but is suitable for and encompasses processing other medical products requiring satisfactory performance of a series of critical steps in the processing or reprocessing of the medical device). For instance (in the endoscope reprocessor example) the monitoring system would insure that the correct steps were performed to disinfect, clean and rinse the endoscope.
By “cleaning” is meant the removal of physical debris from the endoscope. By “disinfecting” is meant the inactivation of biologically active material from the endoscope to a predetermined degree. An example of disinfection is the killing, inhibition, or removal of microorganisms that cause disease. Disinfection may not necessarily eliminate spores or all of the microorganisms from an object or environment. By “sterilizing” is meant the inactivation of biologically active material to a predetermined degree greater than disinfecting. An example of sterilization is a process in which all living cells, spores and viruses are completely destroyed or removed from an object or environment. It is to be understood that while the present invention is described herein with respect to disinfecting and disinfection, the present invention may be used to perform a process that includes only cleaning, or cleaning and disinfecting or disinfecting without cleaning. Furthermore, the present invention may also be used with a process that performs or includes sterilizing, either alone or in combination with cleaning.
In the practice of the present invention, the monitor system has the ability to take control of the hardware performing the processing or reprocessing. In particular with respect to the endoscope reprocessing example, the monitor system will keep the lid (or other access) of the reprocessor closed and not allow it to open (or provide access) until the endoscope is properly reprocessed, or (in the event of an error, access will be denied until the computer acknowledges the error and alerts the operator). It is to be understood that “lid” refers to a means of controlling access to the medical device being processed or reprocessed according to the present invention. If the computer code gets lost or causes improper critical commands (or an improper sequence of commands) to be sent to the reprocessor hardware, the monitor system will provide a warning to the operator that the endoscope has not been properly reprocessed. The monitor system has the ability to communicate directly with the operator. One or more human perceptible indicators, such as visual indicator lights or audible indicator annunciators may be used in the practice of the present invention to indicate normal and or abnormal operating conditions or status of the reprocessing, or that the monitor system has detected a problem.
This arrangement allows the PC or other computer to use its flexibility to the maximum. It can be connected to networks, the web, and any extra software that is needed. The monitor will assure that the medical device works properly. With this arrangement, the monitor system code can go through extensive testing and validation in a reasonable time as it is self-contained and controlled by the manufacturer. The integrity of the medical device and its operation is able to be controlled by well-tested software and the flexibility and upgradability of the computer is not lost.
As mentioned above, while it is possible to use a redundant computer to monitor the operation of the first system, such redundant computer systems often become as complicated as the original system, require extensive testing and are therefore impractical for an application such as endoscope reprocessing.
In contrast, the present invention allows complete software validation of that software that controls the critical aspects of a system without requiring complete validation of a general operating system or applications programs that may be present and active.
The aspects of the invention which are believed to be different from and preferred over known products, machines, processes, or business methods are, in particular, the separation of the critical steps to assure the fact of execution of each critical step and the proper performance of each such step by monitoring with a system that has the ability to directly control the hardware in the event it observes an improper condition.
The present invention has applicability to medical products beyond endoscopes. It could be used for any software controlled system that controls critical steps or processes in relation to a medical device.